GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 68157-60-8
Chemical Name 1-(2-Chloro-4-pyridyl)-3-phenylurea; Forchlorfenuron
Substance ID R01-A-011
Classification year (FY) FY2019
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised New
Classification result in other fiscal year  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
UN GHS document (External link) UN GHS document
Definitions/Abbreviations (Excel file) Definitions/Abbreviations
Model Label by MHLW (External link)  
Model SDS by MHLW (External link)  
OECD/eChemPortal (External link) eChemPortal

PHYSICAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Explosives *
-
-
- - There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."
2 Flammable gases *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
3 Aerosols *
-
-
- - Not aerosol products. It was classified as "Not classified (Not applicable)."
4 Oxidizing gases *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
5 Gases under pressure *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
6 Flammable liquids *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
7 Flammable solids *
-
-
- - No data available. Besides, there is information that it is combustible (GESTIS (Access on June 2019)).
8 Self-reactive substances and mixtures *
-
-
- - There are no chemical groups associated with explosive or self-reactive properties present in the molecule. It was classified as "Not classified (Not applicable)."
9 Pyrophoric liquids *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
10 Pyrophoric solids *
-
-
- - No data available.
11 Self-heating substances and mixtures *
-
-
- - No data available.
12 Substances and mixtures which, in contact with water, emit flammable gases *
-
-
- - The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). It was classified as "Not classified (Not applicable)."
13 Oxidizing liquids *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
14 Oxidizing solids *
-
-
- - The substance is an organic compound containing chlorine and oxygen (but not fluorine) which are chemically bonded only to carbon or hydrogen. It was classified as "Not classified (Not applicable)."
15 Organic peroxides *
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."
16 Corrosive to metals *
-
-
- - Classification is not possible because test methods applicable to solid substances are not available.
17 Desensitized explosives *
-
-
- - There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) *
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified."

[Evidence Data]
(1) LD50 for rats: male: 4,904 mg/kg, female: 4,899 mg/kg (EPA Pesticide (2004))
(2) LD50 for rats: 4,917 mg/kg (EC Draft Renewal Assessment Report (2016))
1 Acute toxicity (Dermal) *
-
-
- - [Rationale for the Classification]
Based on (1), it was classified as "Not classified."

[Evidence Data]
(1) LD50 for rabbits: > 2,000 mg/kg (EPA Pesticide (2004), EC Draft Renewal Assessment Report (2016))
1 Acute toxicity (Inhalation: Gases) *
-
-
- - [Rationale for the Classification]
Solid (GHS definition). It was classified as "Not classified (Not applicable)."
1 Acute toxicity (Inhalation: Vapours) *
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Dusts and mists) *
-
-
- - [Rationale for the Classification]
Based on (1), it was impossible to determine the category. Therefore, it was classified as "Classification not possible."

[Evidence Data]
(1) LC50 for rats: > 3.0 mg/L (EPA Pesticide (2004), EC Draft Renewal Assessment Report (2016))
2 Skin corrosion/irritation *
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified."

[Evidence Data]
(1) In a skin irritation test in which 500 mg of this substance was applied semi-occlusively to the skin of rabbits for 4 hours, no symptoms of erythema, edema and so on were observed. Therefore, it was determined not to be an irritant to the skin (Japanese Journal of Pesticide Science Vol. 23, No.2 (Japan Crop Protection Association, 1998)).
(2) In a test with rabbits, no irritation was observed (EPA Pesticide (2004)).
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
[Rationale for the Classification]
Based on (1) and (2), it was classified in Category 2B.

[Evidence Data]
(1) In an eye irritation test with rabbits, although irritative changes on the cornea and the iris were observed, these effects disappeared after 72 hours. Redness and edema on the conjunctiva were observed after 1 hour of administration, but, these signs disappeared after 72 hours. Therefore, this substance was irritating to the ocular-mucous membrane (Japanese Journal of Pesticide Science Vol. 23, No.2 (Japan Crop Protection Association, 1998)).
(2) In a test with rabbits, mild irritation was observed (EPA Pesticide (2004)).
4 Respiratory sensitization *
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization *
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified."

[Evidence Data]
(1) In a skin sensitization test (Maximization method, details unknown) with guinea pigs, no significant changes on the skin were observed, and it was determined to be negative (Japanese Journal of Pesticide Science Vol. 23, No.2 (Japan Crop Protection Association, 1998)).
(2) In a test with guinea pigs, there is a report of a negative result (EPA Pesticide (2004)).
5 Germ cell mutagenicity *
-
-
- - [Rationale for the Classification]
Based on (1) and (2), although positive findings were observed in some in vitro tests, negative results were shown in other in vitro and in vivo tests. According to expert judgments, this substance was classified as "Not classified."

[Evidence Data]
(1) As for in vivo, a mouse bone marrow micronucleus test and a rat hepatocyte unscheduled DNA synthesis test showed negative results (Japanese Journal of Pesticide Science Vol. 23, No.2 (Japan Crop Protection Association, 1998), EC Draft Renewal Assessment Report (2016)).
(2) As for in vitro, bacterial reverse mutation tests and an in vitro mammalian cell chromosomal aberration test showed negative or positive results. On the other hand, an unscheduled DNA synthesis test by using primary cultures of rat liver cells showed a negative result (HSDB (Access on June 2019), Japanese Journal of Pesticide Science Vol. 23, No.2 (Japan Crop Protection Association, 1998), EC Draft Renewal Assessment Report (2016)).
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Based on (2) and (3), test results of two animal species were negative, however, there are existing classification results in (1) and a report in (4) of an increase in the incidence of kidney tumors in mice in a test conducted in Japan. Therefore, this substance was classified in Category 2.

[Evidence Data]
(1) According to classification results by domestic and international organizations, it was classified as Carc.2 in EU CLP classification (EU CLP classification (Access on June 2019)).
(2) In a 2-year toxicity test with rats dosed by feeding at the highest dosage of 7,500 ppm (male: 352 mg/kg/day, female: 518 mg/kg/day), no increase in the incidence of tumors was observed (EPA Pesticide (2004)).
(3) In an 18-month toxicity test with mice dosed by feeding at up to 1,000 mg/kg/day, no increase in the incidence of tumors was observed (EPA Pesticide (2004)).
(4) In a 2-year toxicity test with rats and mice by feeding, no incidence of tumors in rats was observed, however, in mice, an increase in the incidence of renal cortical epithelial tumors at a dosage of 10,000 ppm was observed in male (Japanese Journal of Pesticide Science Vol. 23, No.2 (Japan Crop Protection Association, 1998)).
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Based on (1) and (2), no reproductive toxicity was observed in 2-generation reproductive toxicity tests. Based on (3) and (4), there was no teratogenicity, but an increase in embryo resorption and a decrease in the number of live fetuses were observed at doses with maternal toxicity. Therefore, it was classified in Category 2.

[Evidence Data]
(1) In a two-generation reproductive toxicity test with rats by the oral route, there was parental toxicity (reduced body weight gain and so on), but no reproductive toxicity (Japanese Journal of Pesticide Science Vol. 23, No.2 (Japan Crop Protection Association, 1998)).
(2) In a two-generation reproductive toxicity test with rats by the oral route, increased kidney weight, suppurative inflammation, cysts, suppurative pyelonephritis and interstitial nephritis in the kidney were observed in parental animals, and a decrease in pup viability was observed, but there was no reproductive toxicity (HSDB (Access on June 2019)).
(3) In a developmental toxicity test in which this substance was administered daily by oral gavage to female rats on Days 6 through 15 of gestation, early and late embryo resorptions, a decrease in fetal body weight, unossified sternebra and reduced ossification of the 13th ribs were found at the dose where mortality (1/25 cases), lethargy, ataxia, scabbing on the abdomen and hind limb, transparent eyes and lower body weight were observed in maternal animals. There was no teratogenicity (HSDB (Access on June 2019)).
(4) In a developmental toxicity test in which this substance was orally administered to female rabbits on Days 6 through 18 of gestation, abortion (2 cases), an increase in embryonic mortality and a trend toward a decrease in the number of live fetuses were found at the dose where decreases in body weight and feed consumption were observed in maternal animals. There was no teratogenicity (Japanese Journal of Pesticide Science Vol. 23, No.2 (Japan Crop Protection Association, 1998)).
8 Specific target organ toxicity - Single exposure Category 2 (central nervous system), Category 3 (respiratory tract irritation)



Warning
H371
H335
P308+P311
P260
P264
P270
P405
P501
P304+P340
P403+P233
P261
P271
P312
[Rationale for the Classification]
There was no report on single exposure in humans. Based on information in (1) and (2) in experimental animals, it was classified in Category 2 (central nervous system) and Category 3 (respiratory tract irritation). There were reference data in (3) in which effects on the central nervous system were suggested, however, these data were not adopted as classification rationale due to unclear descriptions of dosages and administration routes.

[Evidence Data]
(1) In a single dose toxicity test with rats and mice, loss of reflex to sounds and contacts, decreased locomotor activity, rollover, lateral position, supine position, prone position, clonic convulsion, hypothermia, salivation, lacrimation with bloody secretions (eye), ptosis, closing eyelids and stained fur (Japanese Journal of Pesticide Science Vol. 23, No.2 (Japan Crop Protection Association, 1998)). There was no information on the doses where these effects were seen, but, they were supposed to be around LD50 (1,500-2,800 mg/kg, corresponding to or exceeding the range for Category 2).

(2) In a single inhalation exposure test with rats, although the accurate exposure time was unknown, at an exposure concentration of 1.82 mg/L, reddened muzzle immediately after exposure to 1 day after exposure and discharges from the nostrils from 1 day after exposure to 5 days after exposure were observed (Japanese Journal of Pesticide Science Vol. 23, No.2 (Japan Crop Protection Association, 1998)).

[Reference Data, etc.]
(3) In a toxicity test by gavage or intravenous administration of a suspension of this substance in 0.3% CMC or a solution of this substance in 50% PEG-400 to male mice or male rats, decreased locomotor activity, anesthesia enhancing effects, analgesic effects and depressant effects of electro convulsion were observed as treatment-related effects. This substance was considered to affect the central nervous system suppressively. By behavior observations, decreased locomotor activity, gait abnormality and ptosis were observed in a dosage group of 1,000 mg/kg, and subsequently some test animals led to death. The cause of death was considered to be attributed to central nervous system suppression (Japanese Journal of Pesticide Science Vol. 23, No.2 (Japan Crop Protection Association, 1998)).
9 Specific target organ toxicity - Repeated exposure *
-
-
- - [Rationale for the Classification]
Based on (1) to (3), it was classified as "Not classified" (oral).
Besides, there was no information on other routes, therefore, classification was not possible due to lack of data.

[Evidence Data]
(1) In a 90-day toxicity test with mice dosed by feeding of this substance at 900-7,000 ppm, an increase or increasing tendency in bilirubin, increases in relative weight of the liver and kidney and an increased incidence of infiltration of lymphocytes into the interstitium and pelvis in the kidney were observed at 3,500 ppm or 7,000 ppm (converted guidance values: male: 609, 1,288 mg/kg/day, female: 788, 1,683 mg/kg/day, exceeding the range of Category 2) (HSDB (Access on June 2019)).
(2) In a 90-day toxicity test with rats dosed by feeding of this substance at 200-5,000 ppm, an increase in liver weight was observed at 5,000 ppm (converted guidance value: 250 mg/kg/day, exceeding the range of Category 2) (HSDB (Access on June 2019)).
(3) In a 24-month toxicity test with mice dosed by feeding of this substance at 50-10,000 ppm, proliferative lesions of the kidney and mild increases in adrenal subcapsular cell proliferation in males at or above 5,000 ppm (converted guidance value: 750 mg/kg/day, exceeding the range of Category 2), and atrophy and proliferative lesions including hyperplasia of the renal tubular epithelium in males at 10,000 ppm (converted guidance value: 750 mg/kg/day, exceeding the range of Category 2) were observed (Japanese Journal of Pesticide Science Vol. 23, No.2 (Japan Crop Protection Association, 1998)).
10 Aspiration hazard *
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
11 Hazardous to the aquatic environment Short term (Acute) Category 2
-
-
H401 P273
P501
It was classified in Category 2 from 48-hour EC50 = 5.3 mg/L for crustacea (Daphnia magna) (U.S. EPA OPP Pesticide Ecotoxicity Database, 2019).
11 Hazardous to the aquatic environment Long term (Chronic) Category 2


-
H411 P273
P391
P501
Reliable chronic toxicity data were not obtained.
It was classified in Category 2 because it is not rapidly degradable (BIOWIN), and it was classified in Category 2 in acute toxicity.
12 Hazardous to the ozone layer Classification not possible
-
-
- - Classification not possible due to lack of data.


NOTE:
  • GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
  • Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
  • This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
  • Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
  • A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
  • An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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